Specify study, enrollment, and visits settings

Typically, a study manager specifies these settings and it can be done for all modes simultaneously. However, we recommend you set and verify these settings in Testing mode first. These settings apply to all versions of the study and you can edit them at any time. This procedure also applies to rollover studies.`

Tip:

These settings can be modified anytime and apply to all study versions. For guidance on editing the settings, see Updates during the study conduct period.

Want to see how to perform this task? Watch the video below.

Open the study settings.
Below the study name, click the Study Settings tab.
Select a specific study mode:
- Production Settings
- Testing Settings
- Training Settings

Fill in the fields below Study Settings. To view tips for completing a field, click into the field or choose an option.

Option

Description

Allow Subjects to be Manually Added

Choose Yes to let site users manually add subjects to your study.
Choose No to prevent site users from manually adding any subjects to your study.

Replace Subject Number with Randomization Number

This setting is only visible when the permission Manage Subject Number Configuration is added to a study role.

If the setting is grayed out, a subject has already been screened or enrolled in that mode.

Choose Yes to automatically replace the subject number with the randomization number.

Note:
The setting cannot be changed after the first subject has been screened or enrolled.

For more information about this setting, see Setting impacts when replacing a subject number with randomization number.

Allow Site to Select Subject Number

Choose Yes to let site users select subject numbers.
Choose No if subject numbers should be automatically assigned.

Include Hyphen Between Site and Subject Number

Choose Yes to separate the site ID and subject number with a hyphen (for example, 001-001).
Choose No for no hyphen (for example, 001001).

Leading Zeros in First Subject Number

Enter the number of zeros to include at the beginning of the first subject number.

Note that the number of leading zeros decreases as the number of digits in the subject number increases. For example, if you enter 3, the first subject number might be 0001, the 99th subject might be 0099, and the 100th subject might be 0100.

First Subject Number

Enter the number assigned to the first subject in either the study (if subject numbering is sequential in the study) or at each site (if subject numbering is sequential at each site).

Note:

This setting is only available when Allow Site to Select Subject Number is set to No.

Subject Numbering

Select Sequential in Study if subject numbers are sequential across all sites in the study (for example, subject 1 is at Site A, subject 2 is at Site B, and subject 3 is at Site A).
Select Sequential at Sites if subject numbers are sequential at each sites (for example, Sites A and B both have subjects 1, 2, 3, and so on).

Note:

This setting is only available when Allow Site to Select Subject Number is set to No.

Subject Number Format

Specify the characters allowed at each position of the subject number, moving from left to right.

For instance, you can use the expression [0-9] to indicate that in the first position only a single digit between 0 and 9 is allowed. For more details on how to define a subject number format, see What are my options for defining a subject's number format?

Note:

This setting is only available when Allow Site to Select Subject Number is set to Yes.

Withdraw Subjects After Code Break

Choose Yes if subjects are withdrawn from the study after a code break.

A code break is the unblinding of a subject's treatment arm.

Hide the Visit Window Projection

Choose Yes to hide the time frame for scheduled visits under the visit title on the Subjects page.
Choose No to display the time frame for scheduled visits.

Note:
This setting is set to No by default.

Screen Failed Subjects

Select Allow Screen Fail before Screened to allow manual screen failure if subjects have not yet been screened.
Select Allow Withdrawal to allow subjects that have failed screening to withdraw from the study.
Select Allow Completion to allow subjects that have failed screening to complete the study.

Note:

Allow Withdrawal and Allow Completion are deselected by default.

Allow Withdrawal for Subjects before Enrollment

Select the checkbox to allow subjects to withdraw from the study before they've been enrolled.

Display signature elements for site staff and sponsors

Select Yes to allow the Signature widget (

) and Signature Request side panel to appear in the user interface for the corresponding study mode.

Note:

This option is set to No by default and cannot be changed back to No once you have selected Yes.

Code data for new and screen failed subjects

Note:

This setting can be changed at any time. It is set to Yes by default.

Select Yes to allow all verbatim terms to be sent to Oracle Central Coding.
Select No to allow new verbatim terms to be sent to Oracle Central Coding once a subject's status is changed to Enrolled or Active.

Fill in the fields below Enrollment Settings:

Tip:

You don't need to specify limits for every field and in fact probably don't want to. Setting limits on many levels can sometimes result in randomization errors that are difficult to troubleshoot. You can change limits at any time.

Locate the row with the type of limit that you want to set and turn the toggles on and off as required:
- Study Total: Specify limits for the entire study.
- Site Total: Specify limits for sites. All sites are subject to the same limit.
- Country: Specify limits that every country is subject to; or create country-specific limits. To specify country-specific limits, click Add Countries, select your countries, and then enter limits for them.
- Cohorts: Specify a limit for each cohort. Want to know how to open and close a cohort?
  
  Note:
  Only the studies that use a randomization type that requires cohorts will display this field.
For each row, select the checkboxes in the column First Screened Notification or First Randomized Notification, to activate the alerts respectively.

Note:

Activating the notifications is not enough. Users need to have the appropriate permissions assigned to receive these notifications. For more information, see Subject notifications.

For each activated row, fill in the values for:

First screened notification

Select the check-box if you want to receive information about the first screened subjects for either a study or a site.

Note:

The notification will be sent only to those site and sponsor users with permission to receive it. For more information on how to activate the notifications, see First subject screened in study notification.

First randomized notification

Select the check-box if you want to receive information about the first randomized subject for either a study or a site.

Note:

The notification will be sent only to those site and sponsor users with permission to receive it. User Administrators must assign permissions to the users' study role. For more information on how to activate the notifications, see First subject randomized in study notification.

Screening Limits

Enter the maximum number of subjects who can be screened. Screen failures count toward this limit.

After this limit is reached, sites can't add any more subjects.

Tip:

If you want to limit only randomization, for example, you can leave the Screening limit fields blank.
If you want to add screening limits individually by site, click View Sites to go to the Sites & Labs tab. For more information, see Manage screening and randomization limits by site.

Note:

Limits defined on the Sites & Labs tab will override values set in this table.

Randomization Limits

Enter the maximum number of subjects who can be randomized.

After this limit is reached, no subjects can be randomized (even subjects who were already added to the study).

Tip:

If you want to add randomization limits individually by site, click View Sites to go to the Sites & Labs tab. For more information, see Manage screening and randomization limits by site.

Note:

Limits defined on the Sites & Labs tab will override values set in this table.

Notification %

Enter the percentage of subjects in the limit who can be either screened or randomized before a notification occurs. The notification percentage that you specify applies to both the screening and randomization limits.

You can adjust this value throughout the study conduct period so that you receive updates about the number of screened and randomized subjects.

Note:

Subjects from all study versions for a particular study count toward the limits.

If your study includes a minimization design with cohorts, specify enrollment settings for minimization cohorts that have been created in study design.

Fill in the fields below Visit Settings:

Option

Description

Site Enters Visit Dates

Select the types of visits for which site users can select either the current date or an earlier date as the visit start date.

If this setting is checked for a visit, a site user can enter a visit date prior to entering visit data in the form. When data is entered (outside of the Visit Start Date field), the system does not automatically update the visit date to the current date.
If this setting is not checked, a site user cannot enter a visit date prior to entering visit data in the form. When data is entered, the system automatically updates the visit date to the current date.

Site Edits Visit Date

Select the visits for which site users can edit the visit start date after the form has been saved.

The visit schedule is based upon the visit date, and if site users enter data prior to the visit date, the visit schedule might not be calculated as expected. If you expect that site users will enter data for a visit prior to the visit date, consider allowing them to edit the visit date. Otherwise, the visit start date that is recorded might not be accurate.

Tip:

For screening visits, this setting is useful when sites enter data for the screening visit on a later day than when the site user clicked Screen for the subject.
For dispensation visits, this setting is useful when a site must click Dispense prior to the subject coming in for a visit, such as if a pharmacist must prepare the product in advance for the subject.

Visit Date Must Be On or After Randomization

Select if the visit date for the randomization visit must be on or after the date when the site user clicked the Randomize button for the subject.

Tip:

This setting is useful for when a site starts the randomization visit before the visit date. For instance, if a site user starts entering data for a form on Monday, the visit date is set to Monday. However, if the subject doesn't come in until Wednesday, and the site user doesn't click Randomize for the subject until Wednesday, Oracle Clinical One Platform requires the site user to update the Visit Start Date to Wednesday.
This setting is also useful if a site has to complete a randomization visit prior to the subject arriving for a visit, such as for when a compound must be prepared for the subject.

Visit Date Must Be On or After Dispensation

Select if the visit date for the type of visit must be on or after the date when the site user clicked the Dispense button for the subject.

Tip:

This setting is useful for when a site starts the dispensation visit before the visit date. For instance, if a site user starts entering data for a form on Monday, the visit date is set to Monday. However, if the subject doesn't come in until Wednesday, and the site user doesn't click Dispense for the subject until Wednesday, Oracle Clinical One Platform requires the site user to update the Visit Start Date to Wednesday.
This setting is also useful if a site has to complete a dispensation visit prior to the subject arriving for a visit, such as for when a compound must be prepared for the subject.

Visit Can Be Skipped

Select to allow site users to mark a visit as skipped when a subject doesn't come in for a scheduled visit.

If site users skip a dispensation visit, they won't be able to dispense for the visit unless they undo the skip and complete the required fields on the forms in the visit. Site users can always skip optional visits and can never skip the following visits:

Screening and randomization.
A required visit that occurs before the screening visit.
Any visit for which data has been entered.

Send Visit Notification

Select to allow study team members and site users to receive notifications for subjects completing their screening, non-dispensation, optional, and unscheduled visits.

Select Success and Failure to make sure they receive both types of notifications.
Select Failure Only to be notified only when the visit presents errors.

Tip:

This setting is useful for all study team members who should know if subjects have successfully completed their visits, if they couldn't be screened, or if they couldn't successfully go through their visit.

In the upper right, click Apply Changes, then select an option:
- Select the option to apply to the given mode.
- Select Apply to All Modes to use the study settings in all 3 modes.

Specify these settings for other modes in your study, if you haven't already and when required.

Related Topics

Parent topic: Define settings